| Objective To investigate the effect of recombinant human growth hormone (rhGH) administration to postoperative patients on safety and availability with the control group.Methods 48 consecutive patients undergoing the abdominal operation were randomized into the study group or the control group. The study group received rhGH together with standard parenteral and enteral nutrition(PN/EN). The control group received standard PN/EN, but rhGH was placed by placebo. It was isonitrogenous and isocaloric intake in both groups. Each day nitrogen intake 0. 14g/kg, calorie 20kcal/kg. The study group was given daily rhGH (0.15IU·kg-1 · d-1) from the 3rd day to 9th day after operation. Samples were collected before surgery to measure basal values, the 3rd and 10th days to study the rhGH effect. Basal laboratory evaluation, nutritional status and nitrogen balance were measured using standard laboratory techniques. Results Safety: No important adverse event in both groups.Surrogate end point and clinical outcome:(1) Nitrogen balance: Study group: Cumulative nitrogen balance (11.37 + 16.82) g ; Control group: Cumulative nitrogen balance (- 9.11 + 17.52) g, reaching statistical significance, P = 0.000. (2)Nutritional status: The pre- and post-study differences of the plasm albumin, prealbumin, transferrin and fibronectin were no statistical significane, P>0. 05. (3) Immune status: The pre- and post-study difference of the total lymphocyte count were no statistical significane, P>0. 05. (4) The hospitalization cost after surgery: Study group: (3367 + 541)RMB; (3912 + 582)RMB, reaching statistical significance, P = 0.002. (5) NO infective complication was observed in both groups during the therapy. (6) There was no difference of the postoperative hospitalizing days between the groups, P=0. 360.Conclusion rhGH for postoperative patients had better nitrogenbalance, lower cost in the randomized controlled clinical trial. |